Breaking News: The FDA Is Requesting Removal Of All Ranitidine Products (Zantac) From The Market
Zantac and other ranitidine products were withdrawn from the U.S. market after the FDA identified concerns about NDMA contamination and increasing levels of the impurity over time.
Important Update: The FDA requested the withdrawal of all prescription and over-the-counter ranitidine products from the U.S. market on April 1, 2020, after testing showed that NDMA levels in some ranitidine products could increase over time and with higher temperatures. The federal Zantac multidistrict litigation later involved extensive scientific and expert-evidence proceedings, including rulings concerning general causation. Anyone considering a potential claim should have the circumstances of the individual case reviewed rather than relying solely on general information about the litigation.
If you or a loved one previously used Zantac or another ranitidine medication and later developed cancer or another serious medical condition, you may have questions about whether the medication could be relevant to your illness and whether a legal claim may be available.
Attorney Baku N. Patel at Patel Law, PC has represented clients in complex personal injury matters and has handled cases involving significant injuries and damages. If you believe your prior use of Zantac or ranitidine may be relevant to a serious illness, you can contact Patel Law, PC at (217) 384-1111 or schedule a free case evaluation.
What Was Zantac?
Zantac was a brand name for medications containing ranitidine, a histamine-2 receptor antagonist, commonly referred to as an H2 blocker. Ranitidine reduced the amount of acid produced by the stomach and was used to treat conditions including heartburn, acid indigestion, gastroesophageal reflux disease, and certain ulcers.
Ranitidine was available in both prescription and over-the-counter forms. Brand-name Zantac was widely used, and generic versions of ranitidine were also marketed by multiple manufacturers.
Prescription Ranitidine
Ranitidine was prescribed for conditions involving excessive stomach acid, including ulcers and gastroesophageal reflux disease.
Over-the-Counter Zantac
Consumers could purchase certain ranitidine products without a prescription to treat heartburn and related acid-indigestion symptoms.
Generic Ranitidine
Ranitidine was also sold in generic forms manufactured and distributed by multiple pharmaceutical companies.
Why Was Ranitidine Withdrawn From the Market?
In September 2019, the FDA announced that it was investigating reports that ranitidine products could contain N-nitrosodimethylamine, or NDMA. NDMA is classified by the FDA as a probable human carcinogen. The agency continued testing ranitidine products and investigated how the impurity behaved over time.
The FDA ultimately determined that NDMA levels in some ranitidine products could increase with time and when the medication was stored at temperatures higher than room temperature. Based on its laboratory testing and risk assessment, the FDA requested that manufacturers withdraw all prescription and over-the-counter ranitidine products from the U.S. market on April 1, 2020.
FDA Ranitidine Timeline
FDA announced that it was investigating NDMA detected in samples of ranitidine products.
Manufacturers began conducting testing and issuing voluntary recalls of certain ranitidine products.
FDA requested the immediate withdrawal of all prescription and over-the-counter ranitidine products from the U.S. market.
Ranitidine-related product liability litigation continued in federal multidistrict litigation and other proceedings.
The FDA’s action was not based simply on the existence of trace amounts of NDMA. The agency specifically reported that its testing showed that NDMA levels in some ranitidine products could increase over time and under higher-temperature storage conditions, potentially resulting in exposure above the agency’s acceptable daily intake level.
What Is NDMA?
N-nitrosodimethylamine (NDMA) is a chemical compound that can occur as an environmental contaminant and has also been detected as an impurity in certain pharmaceutical products. The FDA classifies NDMA as a probable human carcinogen based on laboratory evidence.
The concern involving ranitidine was that the medication itself could contain NDMA and that the amount could increase under certain conditions. FDA laboratory testing found NDMA in tested ranitidine samples and reported that time and temperature could affect NDMA levels.
NDMA and Cancer Claims
Product liability lawsuits have alleged that exposure to NDMA associated with ranitidine contributed to cancer and that pharmaceutical companies and other defendants should be held legally responsible. Those allegations and the scientific questions surrounding them have been disputed in litigation, and the federal MDL court ultimately entered significant rulings concerning the admissibility of plaintiffs’ expert evidence and general causation.
What Happened in the Federal Zantac Litigation?
Thousands of claims involving Zantac and ranitidine were centralized in the United States District Court for the Southern District of Florida as In re: Zantac (Ranitidine) Products Liability Litigation, MDL No. 2924. The litigation involved personal injury claims, as well as proposed medical-monitoring and economic-loss class actions.
The litigation focused heavily on the scientific question of general causation — whether the scientific evidence could reliably establish that ranitidine can cause the cancers alleged by plaintiffs. The court established a process for evaluating expert testimony and selected several cancer types as “Designated Cancers” for purposes of the general-causation proceedings.
General Causation
This asks whether a substance or product is capable of causing a particular disease or injury in the population generally.
Specific Causation
This addresses whether the product actually caused the particular plaintiff’s illness, taking that person’s circumstances and evidence into account.
In December 2022, the federal MDL court granted the brand defendants’ Daubert motions concerning the plaintiffs’ general-causation expert testimony for the Designated Cancers and granted the defendants’ associated motion for summary judgment. The court’s ruling addressed the scientific evidence presented in the MDL and did not simply constitute a determination that every individual who ever used ranitidine could not have a viable claim under every possible legal theory or in every jurisdiction.
In May 2023, the court entered summary judgment in favor of the personal injury defendants in the MDL on general-causation grounds for the Designated Cancer cases filed before May 5, 2023. The court subsequently established procedures addressing later-filed cases and claims involving cancers outside the Designated Cancers.
Why This Matters: A current Zantac injury page should explain the federal MDL’s scientific and procedural history rather than suggesting that the original 2020 litigation posture remains unchanged. Potential claims can involve different defendants, jurisdictions, procedural histories, medical evidence, and legal theories, so an individual case requires separate evaluation.
Cancer Claims Identified in Zantac Litigation
Plaintiffs in the federal MDL pursued claims involving multiple types of cancer. The five “Designated Cancers” used in the MDL’s general-causation proceedings were bladder, esophageal, gastric, liver, and pancreatic cancer.
The original version of this page also identified colorectal and kidney cancer. Those conditions have appeared in allegations made in Zantac-related litigation, but they were not among the five Designated Cancers for which plaintiffs’ leadership presented general-causation expert reports in the federal MDL. The federal court separately established procedures for cases alleging other cancers.
For that reason, the type of cancer alone does not establish whether a particular person has a viable claim. Medical records, the timing and duration of ranitidine use, the specific product involved, exposure history, diagnosis, applicable law, and available scientific evidence can all be important.
What Evidence May Be Important in a Ranitidine Injury Claim?
A potential pharmaceutical injury case can require substantial documentation. If you or a family member previously used Zantac or another ranitidine product, preserving information about the medication and the resulting medical condition may be important.
Medication History
Prescription records, pharmacy records, receipts, medication lists, photographs, or other documentation showing use of ranitidine may be relevant.
Medical Records
Diagnosis records, pathology reports, treatment records, imaging, physician notes, and other medical documentation can help establish the nature and timing of an illness.
Exposure History
The duration, frequency, approximate dates, dosage, and type of ranitidine product used may be relevant to evaluating a potential claim.
Other Risk Factors
A complete evaluation may also require consideration of other potential causes or risk factors associated with the individual’s medical history.
What Damages May Be Available in a Product Liability Case?
Depending on the facts of the case and applicable law, a successful product liability claim may allow an injured person or surviving family members to seek different categories of damages. Potential damages can include economic and noneconomic losses.
Medical Expenses
Depending on the applicable law, recoverable losses may include medical expenses associated with diagnosis, treatment, hospitalization, medication, rehabilitation, and other care.
Lost Income and Earning Capacity
A serious illness may affect a person’s ability to work, resulting in lost wages or reduced future earning capacity.
Pain and Suffering
Depending on the circumstances, damages may include compensation for physical pain, emotional distress, and other consequences of an injury.
Loss of Enjoyment of Life
A serious illness can interfere with a person’s normal activities, relationships, hobbies, and quality of life.
Punitive damages may also be available in some product liability cases when the applicable law and evidence support such an award. Whether any particular category of damages is available depends on the facts of the case and the governing law.
What Should You Do If You Previously Used Zantac?
If you previously used Zantac or another ranitidine medication and later developed a serious illness, gathering your records can be a useful first step. You do not necessarily need to have the original bottle of medication to begin discussing your circumstances with an attorney.
Identify the Medication
Determine whether you used brand-name Zantac, generic ranitidine, or another product containing ranitidine.
Gather Medical Records
Collect records relating to your diagnosis, treatment, surgeries, medications, and other relevant medical history.
Document Your Ranitidine Use
Write down approximately when you used ranitidine, how frequently you took it, and whether you remember the brand or manufacturer.
Have the Case Evaluated
An attorney can review the available medical, medication, scientific, and legal information to determine whether further investigation is appropriate.
Because pharmaceutical injury claims can involve complicated questions of causation, federal litigation, state law, statutes of limitations, and expert medical evidence, it is important not to assume that a diagnosis alone establishes liability.
Frequently Asked Questions About Zantac and Ranitidine Claims
Is Zantac still available in the United States?
What is NDMA?
Did the federal Zantac litigation establish that ranitidine caused cancer?
What cancers were involved in the federal Zantac MDL?
Do I need to have the original Zantac bottle to discuss a potential claim?
Is there a deadline for bringing a Zantac injury claim?
Sources and Illinois Resources
U.S. Food and Drug Administration:
FDA Requests Removal of All Ranitidine Products From the Market
U.S. Food and Drug Administration:
Questions and Answers: NDMA Impurities in Ranitidine
U.S. Food and Drug Administration:
FDA Laboratory Tests of Ranitidine
U.S. District Court for the Southern District of Florida:
In re: Zantac (Ranitidine) Products Liability Litigation, MDL No. 2924, December 6, 2022 Omnibus Order
U.S. District Court for the Southern District of Florida:
April 6, 2023 Order Concerning Class Proceedings
U.S. District Court for the Southern District of Florida:
Pretrial Order Concerning Later-Filed Designated Cancer Cases
Discuss Your Potential Zantac or Ranitidine Injury Claim
If you or a loved one previously used Zantac or another ranitidine medication and later developed a serious illness, Patel Law, PC can review the circumstances of your potential claim.
Contact Attorney Baku N. Patel for a free case evaluation.
